Azithromycin

In the clinical treatment of common infectious diseases such as lower respiratory tract infection, community-acquired pneumonia, skin and soft tissue infection and sexually transmitted diseases, macrolide antibiotics have always been the first-line treatment option. Among them, azithromycin has become a representative variety of this class of drugs by virtue of its unique pharmacokinetic advantages. Its mechanism of action is to bind to the 50S subunit of bacterial ribosomes to inhibit bacterial protein synthesis. Compared with erythromycin, it has a broader antibacterial spectrum, and has good antibacterial activity against Gram-positive bacteria, some Gram-negative bacteria and atypical pathogens. In addition, it has a long half-life and high tissue permeability, only needs to be administered once a day, and has better patient compliance, and the applicable population covers all age groups including adults, children and elderly patients.

At present, the global market size of azithromycin API is stable at about 1.8 billion US dollars. As the world's largest producer and exporter of azithromycin, China accounts for more than 70% of the global total production capacity, and the domestic market size is nearly 3 billion yuan. After the implementation of the volume-based procurement policy, the terminal price of preparations has dropped significantly. The cost control and supply stability of upstream APIs have become the core competitiveness of downstream enterprises, and the industry concentration has continued to increase. Leading enterprises occupy the main market share by virtue of compliant production capacity and cost advantages, while small and medium-sized production capacity is gradually cleared. The market growth drivers mainly come from the release of demand in the primary medical market and the steady growth of export orders.

The original research enterprise of azithromycin is Pfizer, and the original research trade name is "Zithromax". Its core compound patent expired globally in 2005, and the core preparation patent in China expired in 2007. The main dosage forms of the original research marketed products include tablets, dry suspensions and injections. Common specifications are 250mg and 500mg for tablets, 100mg/bag and 200mg/bag for dry suspensions, and 500mg/vial for injections. The original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparation Catalogue. At present, there are more than 60 registration information of azithromycin API on China's CDE API registration platform, most of which are in A status and can be legally supplied for associated preparation declaration. More than 200 azithromycin preparation varieties have been approved for marketing in China, covering all commonly used dosage forms. (Data as of July 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of azithromycin impurity reference standards. The products meet the quality compliance requirements under multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most impurities are available from stock. In-stock orders placed before 16:00 can be shipped on the same day, which can fully meet the various reference standard needs of API enterprises in the stages of process research and development, quality research and declaration and registration.